上海医药
上海醫藥
상해의약
SHANGHAI MEDICAL & PHARMACEUTICAL JOURNAL
2013年
3期
36-38
,共3页
强直性脊柱炎%重组人 II 型肿瘤坏死因子受体 - 抗体融合蛋白%甲氨蝶呤%柳氮磺吡啶
彊直性脊柱炎%重組人 II 型腫瘤壞死因子受體 - 抗體融閤蛋白%甲氨蝶呤%柳氮磺吡啶
강직성척주염%중조인 II 형종류배사인자수체 - 항체융합단백%갑안접령%류담광필정
ankylosing spondylitis%etanercept%methotrexate%sulfasalazine
目的:评价重组人 II 型肿瘤坏死因子受体-抗体融合蛋白治疗强直性脊柱炎的临床疗效和安全性.方法:选取2007年1月-2011年12月,本科收治的强直性脊柱炎活动性患者56例,随机分为治疗组与对照组,每组28例患者.治疗组患者予以依那西普(50 mg,1次/周皮下注射)治疗;对照组患者给予甲氨蝶呤(10~15 mg/周)和柳氮磺吡啶(1.5~2.0 g/d)联合治疗,两组均同时给予非甾体类抗炎药(NSAIDs)治疗.疗程12周后评价腰痛发生率、腰部晨僵时间、实验室炎症反应指标:红细胞沉降率(ESR)和 C 反应蛋白(CRP)、血小板计数(PLT)及 BASDAI、BASFI 评分等,随时记录观察期间不良事件.结果:两组治疗12周后与各自基线相比,腰痛发生率明显降低(P<0.05),腰部晨僵时间明显缩短(P<0.05),BASDAI、BASFI 评分明显改善,ESR、CRP、PLT 明显降低(P<0.05);治疗组各项临床指标改善程度均明显优于对照组(P<0.05);两组患者不良反应发生率比较差异无统计学意义(P>0.05).随访过程中,治疗组患者降低依那西普用药频率继续使用,病情维持稳定.不良反应均为轻度,未发现结核、病毒性肝炎感染等情况.结论:依那西普治疗强直性脊柱炎的临床疗效显著,且安全性较高.
目的:評價重組人 II 型腫瘤壞死因子受體-抗體融閤蛋白治療彊直性脊柱炎的臨床療效和安全性.方法:選取2007年1月-2011年12月,本科收治的彊直性脊柱炎活動性患者56例,隨機分為治療組與對照組,每組28例患者.治療組患者予以依那西普(50 mg,1次/週皮下註射)治療;對照組患者給予甲氨蝶呤(10~15 mg/週)和柳氮磺吡啶(1.5~2.0 g/d)聯閤治療,兩組均同時給予非甾體類抗炎藥(NSAIDs)治療.療程12週後評價腰痛髮生率、腰部晨僵時間、實驗室炎癥反應指標:紅細胞沉降率(ESR)和 C 反應蛋白(CRP)、血小闆計數(PLT)及 BASDAI、BASFI 評分等,隨時記錄觀察期間不良事件.結果:兩組治療12週後與各自基線相比,腰痛髮生率明顯降低(P<0.05),腰部晨僵時間明顯縮短(P<0.05),BASDAI、BASFI 評分明顯改善,ESR、CRP、PLT 明顯降低(P<0.05);治療組各項臨床指標改善程度均明顯優于對照組(P<0.05);兩組患者不良反應髮生率比較差異無統計學意義(P>0.05).隨訪過程中,治療組患者降低依那西普用藥頻率繼續使用,病情維持穩定.不良反應均為輕度,未髮現結覈、病毒性肝炎感染等情況.結論:依那西普治療彊直性脊柱炎的臨床療效顯著,且安全性較高.
목적:평개중조인 II 형종류배사인자수체-항체융합단백치료강직성척주염적림상료효화안전성.방법:선취2007년1월-2011년12월,본과수치적강직성척주염활동성환자56례,수궤분위치료조여대조조,매조28례환자.치료조환자여이의나서보(50 mg,1차/주피하주사)치료;대조조환자급여갑안접령(10~15 mg/주)화류담광필정(1.5~2.0 g/d)연합치료,량조균동시급여비치체류항염약(NSAIDs)치료.료정12주후평개요통발생솔、요부신강시간、실험실염증반응지표:홍세포침강솔(ESR)화 C 반응단백(CRP)、혈소판계수(PLT)급 BASDAI、BASFI 평분등,수시기록관찰기간불량사건.결과:량조치료12주후여각자기선상비,요통발생솔명현강저(P<0.05),요부신강시간명현축단(P<0.05),BASDAI、BASFI 평분명현개선,ESR、CRP、PLT 명현강저(P<0.05);치료조각항림상지표개선정도균명현우우대조조(P<0.05);량조환자불량반응발생솔비교차이무통계학의의(P>0.05).수방과정중,치료조환자강저의나서보용약빈솔계속사용,병정유지은정.불량반응균위경도,미발현결핵、병독성간염감염등정황.결론:의나서보치료강직성척주염적림상료효현저,차안전성교고.
Objective: To evaluate the clinical efficacy and safety of recombinant human type II tumor necrosis factor receptor-antibody fusion protein (etanercept) in the treatment of ankylosing spondylitis. Methods: Fifty-six patients with ankylosing spondylitis hospitalized in our department from January 2007 to December 2011 were randomly divided into either a treatment group or a control one with 28 patients each. The patients in the treatment group were subcutaneously injected 50 mg of etanercept once a week while the patients in the control group were administrated with methotrexate (10~15 mg/week) and sulfasalazine (1.5~2.0 g/d). Besides, all patients had the addition of non-steroidal anti-inflammatory drugs (NSAIDs). The incidence of lumbago, duration of morning stiffness of waist, inflammatory markers and so on were evaluated at baseline after 12 week treatment and the adverse events were recorded during the observation period. Results: The improvement of clinical indicators was significantly better in the treatment group than in the control group (P<0.05). The incidence of adverse reactions in two groups showed no significant difference (P<0.05). Conclusion: Etanercept is safe and effective in the treatment of ankylosing spondylitis.
